To improve the patient experience, the organizations that sponsor and conduct clinical trials are turning to mobile technology that’s already in use. As clinical research evolves toward a more patient-centric model, mobile data collection through smartphones and apps provide sponsors and CROs with a new stream of valuable data that can help address questions unique from those investigators have asked in traditional trials.
By immersing patients in their trials – its components and terminology, objectives, risks, benefits – drug and medical device developers have the opportunity to change the entire concept of patient “outcomes” while improving trial success rates.
Below are the details of two studies presented at the recent 60th Annual Meeting of the American Society of Hematology (ASH) that leveraged Medidata’s platform — including Rave, Rave eCOA/ePRO, and Rave Omics — to overcome complex trial challenges by simplifying patient engagement.
Adverse Event Data Reporting From Oncology Patients
The National Cancer Institute (NCI) has developed software to gather symptomatic adverse events directly from clinical trial patients. NCI surveys patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through web-based or automated telephone interfaces and facilitates clinicians’ and research associates’ management of survey administration and data through Rave EDC.
The NCI recently evaluated the software’s usability in a study published in JMIR Human Factors, and the resulting modifications improved the system. The data informed the specifications for the functionalities of a mobile app version of the PRO-CTCAE data implemented on Medidata’s Rave eCOA/ePRO. The PRO-CTCAE software has been implemented in at least five large NCI-sponsored multicenter cancer clinical trials, with more to follow.
Understanding the toxicity of oncology treatments and their impact on patients is vital, and tools for simplifying patients’ reporting of their events and allowing researchers to monitor and analyze this data holds the promise of accelerating the go/no-go decision-making process as well as time-to-market for potentially life-saving treatments.
Wearable Technology Assesses Wellness and Health of Patients During Chemotherapy
In a study presented at ASH, investigators asked whether mobile wearable technology can establish patterns of sleep and wake states in newly diagnosed multiple myeloma (NDMM) patients receiving therapy and whether these patterns differ over time.
NDMM patients received Garmin Vivofit devices with the Medidata Rave ePRO app on their phone/tablet. Patients were bio-monitored for physical activity and sleep during a baseline period (1–7 days before chemotherapy initiation) and continuously for up to six cycles of chemotherapy. Data about activity, sleep, and completed ePRO questionnaires were automatically synced or transferred to Medidata Rave via Medidata’s SensorLink technology.
When pre- and post-therapy mean activity was compared, patients above and below 65 years old had increased 8.6% and 52%, respectively. Short-term effects of therapy initiation were evaluated by comparing percent changes in activity (number of steps per 24 hours) from baseline to cycle 1. Three patients had a >100% increase, one had 50–100% increase, and 11 had within +/-50% change. It was concluded that such monitoring in symptomatic NDMM patients may be a useful tool to assess overall wellness and health during chemotherapy.
For greater insight into the patient experience, the inclusion of wearables and sensors in clinical research is a key area of interest for the industry, and this research highlights the unique perspective this technology can provide.